Clinical Audits

PSC’s seasoned staff provides auditing services for clinical research sites, vendor audits for sponsors, and IRB audits.

 

PSC audits clinical research sites for compliance with:

  • GCP (FDA and ICH)
  • GLP
  • EMEA regulations
  • National Cancer Institute protocols and requirements
  • Other regulatory requirements

PSC audits vendors for sponsors for:

  • Pre-clinical
  • Phase I – III sites
  • Data management companies
  • Safety laboratories
  • Bioanalytical laboratories
  • Internal sponsor audits

PSC’s IRB audits assure that patient safety is being met and that your IRB meets Federal and International guidelines.

 

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